Q&A With Michael Taylor, Part I: The Next FSMA Rules and Imports

A conversation with FDA Deputy Commissioner of Foods and Veterinary Medicine Michael Taylor on the coming foreign supplier verification rule and how the Food Safety Modernization Act aims to overhaul import oversight

Q: I know you can’t talk timing specifics, but what can you tell us about the yet-to-be-released FSMA rules that the food industry is anxiously anticipating? When they are released, how will it all work with the other rules [produce safety and preventive controls] going forward?

A: The details about how we’re going to make all of this mesh remain to be seen, but we want people to be able to see these critical rules as a package. Particularly the foreign supplier verification program rule, which is very closely connected with the produce safety and preventive controls rules. It’s very important that people see these together. That’s why we’re eager to get the foreign supplier verification proposal out as soon as possible, to give people a chance to comment on the package, as a package.

Q: So will foreign supplier verification be out first?

A: It remains to be seen how these will roll out. We’re working on all of the remaining three, which include the preventive controls for animal feed and pet food facilities, and the two rules that are import-oriented: the foreign supplier verification rule and the accredited third-party certification proposal. We’re eager to get the whole framework out.

Q: Are there substantive issues still being worked out at the Office of Management and Budget – why the delay?

A: It’s the normal [Office of Information and Regulatory Affairs] and inter-agency process that just has to complete itself. It’s part of the normal flow of what it takes to get large, complicated rules out the door. Folks are working hard and there’s a lot recognition about the importance of getting the next three out.

Q: When foreign supplier verification does roll out – how critical of a change will that be? It seems we haven’t been able to inspect more than a tiny percentage of the food imports flooding in…

A: This is hugely important to the future success of FSMA implementation – to get the foreign supplier verification program rule on the books and to be able to implement it. It’s how we’ll fulfill the vision of FSMA and ensure that the same standards that we’re creating for domestic growers and processors will apply to foreign product as well.

FSMA is clear that the same standards do apply, but then the question is: how can we ensure that they’re being met? That’s where the foreign supplier verification program comes in. It’s part of this shift from reaction to prevention – to having much higher levels of assurance that prevention standards are being met. The shift is from the current import oversight system, which relies primarily on FDA inspectors at ports-of-entry screening, but only a percent or two of products are actually physically examined. If we find a problem, we can keep the goods from coming in, but the burden is on us to find the problem.

What FSMA says is that the importer has a responsibility to verify that problems are being prevented by virtue of the standards that the foreign grower or processors are working under. These have to be the same as our standards, or be similar modern preventive standards that achieve the same level of public health protection and the importer has to verify, in a documented way, that the foreign grower or processor is in fact operating under those conditions.

It’s a big shift from reaction to prevention and to much stronger responsibility and accountability for the importer, who is the U.S.-based entity over whom we have direct jurisdiction.

Q: How do you envision being able to enforce this? As we’ve seen it’s not difficult to come up with paperwork that looks good. What will FDA’s role be in ensuring the accuracy of verification documents?

A: I think this is one of the strengths of FSMA, that it gives us multiple tools and doesn’t depend on any one thing to provide these assurances. I think we do consider the foreign supplier verification program to be the foundation for a much stronger prevention approach.Firms will have to take responsibility, they will have to have a system and conduct verification commensurate with risks – and we’ll be able to audit those systems.

We can also check product that’s coming in. If we audit an importer and we have any question at all about whether they’re doing it right, or even if we don’t have a question, we can choose to actually sample the product we’re bringing in as a check on what the records are showing us. The other element to this toolkit is our stronger presence overseas. We want to maintain and improve the targeting of these inspections – that’s another check on the system.

We have new authority that says if a foreign supplier doesn’t let us inspect them, we can stop their product from coming in. Finally, we’re charged with working more closely with foreign governments. We’re pursuing various ways to strengthen our partnerships and, where appropriate, to rely on what foreign governments do.

There are multiple elements that are going to result in much elevated levels of assurance. No system is ever going to be perfect, but when you compare now and what we rely on, fundamentally – this very small percentage of product inspected at ports-of-entry – to a system based on prevention that makes industry responsible for having systems in place and then all these other checks– it’s a huge leap forward.

Q: It is shocking to consumers is that only 1-2% of food coming in is physically inspected – I know there have been efforts to make that more targeted – but as FSMA moves forward, will FDA inspect a higher percentage of imported food at ports-of-entry? Or is that to be determined?

A: Well, that’s to be determined with a couple considerations in mind. One, obviously, is funding. We need additional resources to implement this new import oversight system. We can’t do it without additional resources. I think the question we always have to ask ourselves, with the next increase of resources in the import arena, is: where would we want to put those resources? I think we would certainly place a priority on implementing the foreign supplier verification program, which is a powerful new tool for leveraging what the industry does and giving us a much better way to judge whether preventive systems are in place, rather than relying on our own efforts.

It’s not that we would stop doing product exams at the port-of-entry. I think we have to figure out what the right mix is, in conjunction with auditing foreign supplier verification programs and the other things we can do under FSMA.